Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ

Phase 4

• Conditions: Nasal and Nasal-type NK/T-cell Lymphoma
• Interventions: Drug: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase); Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）

• Registration Number: NCT01501149
• Lead Sponsor: Mingzhi Zhang

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.

Detailed Description

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-25
• Study First Posted: 2011-12-29
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-17
• Primary Completion: 2015-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
• Histological confirmed NK/T cell lymphoma
• None of chemotherapy or radiotherapy has been previously used
• None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
• At least one measurable lesion
• None of other serious diseases, cardiopulmonary function is normal
• Pregnancy test of women at reproductive age must be negative
• Patients could be followed up
• None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
• volunteers who signed informed consent.

Exclusion Criteria

• Disagreement on blood sample collection
• Patients allergic of any of drug in this regimen or with metabolic disorder
• Pregnant or lactating women
• Serious medical illness likely to interfere with participation
• Serious infection
• Primitive or secondary tumors of central nervous system
• Chemotherapy or radiotherapy contraindication
• The evidence of CNS metastasis
• History of peripheral nervous disorder or dysphrenia
• patients participating in other clinical trials
• patients taking other antitumor drugs
• patients estimated to be unsuitable by investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DDGP regiment	DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)	DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
SMILE Regiment	Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）	Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment

Primary Outcome Measures

Name	Time	Method
Progression-free survival	up to end of follow-up-phase (approximately 24 months)

Secondary Outcome Measures

Name	Time	Method
median survival time	24 months
response rate	every 6 weeks,up to completion of treatment(approximately 18 weeks )	21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
overall survival	up to the date of death (approximately 5 years)

Trial Locations

Locations (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China